Alice B. Gottlieb, B. Strober, Georgios Kokolakis, Joseph F. Merola, Min Zheng, Richard G. Langley, Ming Tang, Patrick Hofmann, C. Thoma, Richard B Warren
{"title":"根据皮肤科生活质量指数评分,斯派索利单抗可迅速改善泛发性脓疱型银屑病患者的生活质量:来自 Effisayil 2 试验的数据","authors":"Alice B. Gottlieb, B. Strober, Georgios Kokolakis, Joseph F. Merola, Min Zheng, Richard G. Langley, Ming Tang, Patrick Hofmann, C. Thoma, Richard B Warren","doi":"10.25251/skin.8.supp.409","DOIUrl":null,"url":null,"abstract":"Introduction Generalized pustular psoriasis (GPP) is a chronic and potentially life-threatening disease characterized by flares of widespread skin pustulation. In Effisayil 2 (NCT04399837), high‑dose spesolimab was superior to placebo in GPP flare prevention and numerically reduced the risk of Dermatology Life Quality Index (DLQI) worsening (≥4-point increase in total score from baseline; secondary endpoint), up to Week 48. \nMethods Here, we further analyze the effect of high-dose spesolimab versus placebo on DLQI in Effisayil 2. \nResults Baseline characteristics were generally similar in the high-dose spesolimab (600 mg loading dose then 300 mg every 4 weeks [N=30]) and placebo groups (N=31) in terms of sex, age, length of disease, and historical flare frequency, although the high‑dose spesolimab group had a higher mean±SD DLQI score (11.1±6.9 [missing=1]) versus placebo (7.2±5.6 [missing=0]). At Week 4 in exploratory analysis, more patients in the high-dose spesolimab group (N=29) had no GPP flare and ≥4-point improvement in their DLQI score versus placebo (N=31) (n/N [%]: 10/29 [34.5%] [missing=1] versus 3/31 [9.7%] [missing=0]) at Week 4; this was also seen at Week 48 (11/29 [37.9%] [missing=6] versus 8/31 [25.8%] [missing=0], respectively). Furthermore, a higher proportion of patients treated with spesolimab had no GPP flare and reached a DLQI score of 0 or 1 at all visits up to Week 48 versus placebo (7/29 [24.1%] versus 1/31 [3.2%], respectively). \nConclusion Adding to previous data from Effisayil 2, this analysis demonstrates that patients treated with spesolimab (including high-dose) rapidly gained improvements in DLQI scores versus placebo, which were sustained through to Week 48.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Spesolimab Rapidly Improves Quality of Life in Patients with Generalized Pustular Psoriasis, as per Dermatology Life Quality Index Scores: Data from the Effisayil 2 Trial\",\"authors\":\"Alice B. Gottlieb, B. Strober, Georgios Kokolakis, Joseph F. Merola, Min Zheng, Richard G. Langley, Ming Tang, Patrick Hofmann, C. Thoma, Richard B Warren\",\"doi\":\"10.25251/skin.8.supp.409\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Introduction Generalized pustular psoriasis (GPP) is a chronic and potentially life-threatening disease characterized by flares of widespread skin pustulation. In Effisayil 2 (NCT04399837), high‑dose spesolimab was superior to placebo in GPP flare prevention and numerically reduced the risk of Dermatology Life Quality Index (DLQI) worsening (≥4-point increase in total score from baseline; secondary endpoint), up to Week 48. \\nMethods Here, we further analyze the effect of high-dose spesolimab versus placebo on DLQI in Effisayil 2. \\nResults Baseline characteristics were generally similar in the high-dose spesolimab (600 mg loading dose then 300 mg every 4 weeks [N=30]) and placebo groups (N=31) in terms of sex, age, length of disease, and historical flare frequency, although the high‑dose spesolimab group had a higher mean±SD DLQI score (11.1±6.9 [missing=1]) versus placebo (7.2±5.6 [missing=0]). At Week 4 in exploratory analysis, more patients in the high-dose spesolimab group (N=29) had no GPP flare and ≥4-point improvement in their DLQI score versus placebo (N=31) (n/N [%]: 10/29 [34.5%] [missing=1] versus 3/31 [9.7%] [missing=0]) at Week 4; this was also seen at Week 48 (11/29 [37.9%] [missing=6] versus 8/31 [25.8%] [missing=0], respectively). Furthermore, a higher proportion of patients treated with spesolimab had no GPP flare and reached a DLQI score of 0 or 1 at all visits up to Week 48 versus placebo (7/29 [24.1%] versus 1/31 [3.2%], respectively). \\nConclusion Adding to previous data from Effisayil 2, this analysis demonstrates that patients treated with spesolimab (including high-dose) rapidly gained improvements in DLQI scores versus placebo, which were sustained through to Week 48.\",\"PeriodicalId\":22013,\"journal\":{\"name\":\"SKIN The Journal of Cutaneous Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-07-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"SKIN The Journal of Cutaneous Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.25251/skin.8.supp.409\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"SKIN The Journal of Cutaneous Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.25251/skin.8.supp.409","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Spesolimab Rapidly Improves Quality of Life in Patients with Generalized Pustular Psoriasis, as per Dermatology Life Quality Index Scores: Data from the Effisayil 2 Trial
Introduction Generalized pustular psoriasis (GPP) is a chronic and potentially life-threatening disease characterized by flares of widespread skin pustulation. In Effisayil 2 (NCT04399837), high‑dose spesolimab was superior to placebo in GPP flare prevention and numerically reduced the risk of Dermatology Life Quality Index (DLQI) worsening (≥4-point increase in total score from baseline; secondary endpoint), up to Week 48.
Methods Here, we further analyze the effect of high-dose spesolimab versus placebo on DLQI in Effisayil 2.
Results Baseline characteristics were generally similar in the high-dose spesolimab (600 mg loading dose then 300 mg every 4 weeks [N=30]) and placebo groups (N=31) in terms of sex, age, length of disease, and historical flare frequency, although the high‑dose spesolimab group had a higher mean±SD DLQI score (11.1±6.9 [missing=1]) versus placebo (7.2±5.6 [missing=0]). At Week 4 in exploratory analysis, more patients in the high-dose spesolimab group (N=29) had no GPP flare and ≥4-point improvement in their DLQI score versus placebo (N=31) (n/N [%]: 10/29 [34.5%] [missing=1] versus 3/31 [9.7%] [missing=0]) at Week 4; this was also seen at Week 48 (11/29 [37.9%] [missing=6] versus 8/31 [25.8%] [missing=0], respectively). Furthermore, a higher proportion of patients treated with spesolimab had no GPP flare and reached a DLQI score of 0 or 1 at all visits up to Week 48 versus placebo (7/29 [24.1%] versus 1/31 [3.2%], respectively).
Conclusion Adding to previous data from Effisayil 2, this analysis demonstrates that patients treated with spesolimab (including high-dose) rapidly gained improvements in DLQI scores versus placebo, which were sustained through to Week 48.